Commentary
Video
Author(s):
David Samuel Dicapua Siegel, MD, emphasizes the importance of real-world evidence when treating patients with relapsed/refractory multiple myeloma.
David Samuel Dicapua Siegel, MD, medical oncologist, chief, Myeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, discusses the importance of utilizing real-world evidence when making treatment considerations, specifically in the treatment of patients with relapsed/refractory multiple myeloma, emphasizing the need for real-world investigations in this patient population.
Transitioning from clinical trials to real-world applications poses a complex challenge for patients with relapsed/refractory multiple myeloma, Siegel begins. Clinical trials are bound by strict eligibility criteria, resulting in a highly selected participant pool, Siegel says. Conversely, real-world data offer a more inclusive perspective, he states. In the realm of myeloma management, the focus has shifted toward CAR T cells and T-cell engagers, with 2 main commercially available products–idecabtagene vicleucel (ide-cel; Abecma) and ciltacabtagene autoleucel (cilta-cel; Carvykti)–gaining prominence, Siegel explains. Notably, ide-cel received FDA approval in March 2021 and cilta-cel was granted FDA approval in February 2022, both for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy.
Real-world outcomes with ide-cel and cilta-cel echo findings from the pivotal clinical trials, affirming the remarkable efficacy of both therapies, he expands. In the real-world setting, ide-cel exhibits slightly lower effectiveness than cilta-cel, a finding which aligns with clinical trial observations, Siegel states. However, ide-cel boasts the advantages of lower toxicity and enhanced applicability vs cilta-cel, ensuring a higher likelihood of successful product manufacturing and expedited delivery to patients, he emphasizes. Siegel goes on to say that these factors are crucial for a subset of patients facing time constraints, for whom the risk of manufacturing failure or prolonged waiting periods, as seen with ide-cel, is not feasible.
Although real-world data support these observations, making direct comparisons between ide-cel and cilta-cel remains a challenge, he continues. Patients with more severe conditions tend to opt for the product with greater manufacturing reliability and shorter turnaround time, raising ongoing questions that require comprehensive exploration, Siegel concludes.